Spirus Medical, Inc. (Spirus Medical), is planning to complete the clinical study entitled “Efficacy And Safety Of The Uro-Ease Urinary Catheter During Clean Intermittent Catheterization” for Uro-Ease by December 2010. The trial is currently recruiting participants in US with estimated enrollment of 25. The purpose of the trial is to evaluate the ease of use and comfort of the Uro-Ease, as used in the Clean Intermittent Catheterization (CIC)process. The study Principal Investigator is John T. Stoffel, M.D. from Lahey Clinic, Inc.
This case-crossover, prospective study is of two phases. The first phase is observational with five patients meeting the inclusion criteria will be consented from the Urology Clinic. Participating Urology nurses who have been previously trained in the utilization of the Spirus Catheter, will perform the initial CIC on the patient with a 12 Fr Spirus Catheter(choice of 2 different flexibilities). The study nurse will document time per catheterization and effective drainage of bladder. Before leaving the clinic, patient’s will be instructed in the use of the Spirus Catheter and demonstrate efficacy with using the Spirus Catheter. Patients will then fill out VAS Forms for ease and comfort of catheter insertion and after each subsequent catheterization. Patients will also record, for 3 consecutive days, time it takes for catheterization and time to drain the bladder . Patients will return to clinic in 1 week to return VAS forms and documentation. A follow-up phone call will be made to the patient in month to check on patient’s status. All patients will be instructed to call clinic, nurse or on-call-urologist for any report of urethral trauma, which will be evaluated with flexible cystoscopy. These reports will be reviewed and documented.
The second is a randomized cross over trial with 20 patients. After successful completion of Phase 1, patients will be randomized into 2 groups-10 patients will first be randomized into the Spirus Catheter Group and 10 patients into the Standard 12 FR Bard Catheter Group.(Coude’ or straight catheters may be utilized for standard group) As in Phase 1, all patients will receive CIC instruction for self-catheterization, specific to the selected catheter and can demonstrate efficacy with CIC using selected catheter, before they leave the clinic. Patients will then fill out VAS forms for catheter insertion ease and comfort and after each subsequent catheterization.
Patient will also record time per catheterization and bladder drainage for 3 consecutive days. Patients will return to the clinic in 1 week for a progress report, return VAS forms and reports. At this time the patient will be switch over to the alternate catheter group for 1 week. All patients will be instructed to call clinic, nurse or on-call-urologist for any report of urethral trauma, defined as blood on catheter or per meatus. Any occurence of urethral trauma will be evaluated with flexible cystoscopy. These reports will be reviewed and documented. All patients will be followed up to one month to check on the patient’s status.
Uro-Ease urinary catheter has a rounded helical thread formed on the surface of its distal end for use in clean intermittent cathterization. It will incorporate endoluminal advancement system, a rotate to advance technology used to access urological lumens.